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EXPLORER PET/CT Scan for Healthy Subjects
N/A
Waitlist Available
Led By Lorenzo Nardo, MD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximatively 12 hours
Awards & highlights
Study Summary
This trial is testing a new CT scanner that may help doctors better understand and treat diseases.
Who is the study for?
This trial is for healthy men and women, 18 or older, who can lie still for scans lasting 60 and 20 minutes. Participants must fast for at least 6 hours before the scan. Those with a body weight over 240 kg, certain allergies, kidney issues, recent major health treatments like chemotherapy or surgery, diabetes, high fasting blood glucose levels or standard MRI contraindications cannot join.Check my eligibility
What is being tested?
The study tests a new FDA-cleared PET/CT scanner called EXPLORER that performs total body scans. It aims to collect preliminary data on how well this technology works in scanning the entire body of healthy volunteers.See study design
What are the potential side effects?
Since this trial involves imaging using a PET/CT scanner rather than medication or invasive procedures, side effects are minimal but may include discomfort from lying still and potential reactions to iodine contrast used in some cases.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximatively 12 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximatively 12 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Coefficient of variation. SD/mean (Standard deviation divided by mean value)
Standardized Uptake Value
Standardized Uptake Value SUV(t)= C(t)/(ID/BW) C(t) is radioactivity measured from an image at the time t, decay corrected to t=0 and converted from a volume to a mass based unit via the factor 1/(1 g/mL) ID: the injected dose at t=0 BW= Body weight
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: low FDG dose imagingExperimental Treatment1 Intervention
0.5 mCi of 18F-FDG (1/20th of the standard dose) will be hand injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. The dynamic scan will be preceded by an ultra-low-dose CT scan (1.298 mSv) for attenuation correction. The standard 20-minute EXPLORER scan obtained at 90 minutes will be obtained after a low dose CT (7.44 mSv) for attenuation and co-localization. The standard 20-minute EXPLORER scan obtained at 3 hours will be preceded by an ultra-low-dose CT scan (1.298 mSv) for attenuation correction only. MRI Brain will be also obtained after PET/CT scanning for anatomic correlation.
Group II: delayed imaging acquisitionExperimental Treatment1 Intervention
10 mCi of 18F fluorodeoxyglucose (FDG) will be injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. The IV line will be removed after dynamic acquisition. The dynamic scan will be preceded by ultra low-dose (1.298 mSv) CT scan to provide information for attenuation correction for the PET data. At 90 minutes, 3-, 6-, 9- and 12-hours, a static whole-body scan for 20 minutes will be acquired on EXPLORER. Prior to the 90-minute scan a low-dose CT (7.44 mSv) will be obtained both for anatomic localization and for attenuation correction purposes. Prior to each of the later time-points (3-, 6-, 9- and 12-hours), an ultra low-dose (1.298 mSv) CT scan will be acquired. This scan will be for attenuation correction purposes only. Following the 12-hour scan, the participant's study visit will be completed. MRI Brain will be also obtained after PET/CT scanning for anatomic correlation.
Group III: comparison PET images reconstructed using CT-based attenuationExperimental Treatment1 Intervention
10 mCi of 18F-FDG will be hand injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. Prior to the dynamic scan, an ultra-low-dose CT scan (1.298 mSv) will be acquired for attenuation correction purposes only. At 90 mins, a low dose non contrast enhancement CT (7.44 mSv) will be acquired vertex to toes. Iodinated contrast (150 cc of iodine Omnipaque 350) will then be intravenously injected (through the same IV placed to inject FDG) at 3 ml/sec while the patient remains still on the scanner and a second low-dose CT will be acquired. Finally, a 20-minute PET acquisition will be performed. The IV line will be removed after completion of the study. MRI Brain will be also obtained after PET/CT scanning for anatomic correlation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EXPLORER PET/CT
2021
N/A
~20
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
910 Previous Clinical Trials
4,706,946 Total Patients Enrolled
Lorenzo Nardo, MDPrincipal InvestigatorUniversity of California, Davis
3 Previous Clinical Trials
242 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are willing and able to lie in a supine position for 60 and 20 minutes at separate timepoints.
Research Study Groups:
This trial has the following groups:- Group 1: comparison PET images reconstructed using CT-based attenuation
- Group 2: delayed imaging acquisition
- Group 3: low FDG dose imaging
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Healthy Subjects Patient Testimony for trial: Trial Name: NCT04110743 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What hazards do patients need to be aware of when undergoing this treatment?
"As this treatment is currently in Phase 1, our team at Power has quantified the safety of it as a 1 due to limited clinical data available."
Answered by AI
Is the research team currently seeking volunteers for this experiment?
"Contrary to what one might expect, the information posted on clinicaltrials.gov states that this particular trial is no longer accepting patients as it was last updated on August 3rd 2022. Despite this, there are currently 840 other medical studies actively recruiting participants."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
University of California, Davis
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
Why did patients apply to this trial?
I like helping the advancement of medicine.
PatientReceived 2+ prior treatments
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